Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorValenta Pharm JSC
About this trial
This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses compared to placebo in patients with chronic cholecystitis and biliary dyskinesia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females aged 18-70 years.
Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).
Presence of pain/discomfort in the upper abdomen combined with at least one of the following symptoms: Heartburn; Belching; Nausea; Abdominal bloating; Borborygmi (stomach rumbling); Flatulence; Constipation; Diarrhea.
Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
Disqualifiers
Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
Ineffectiveness of therapy. The therapy will be deemed ineffective if there is no clinical improvement by visit 3 (15±1 days of therapy) - persistence or increase in the severity of pain/discomfort in the upper abdomen on the VAS compared to baseline. If excluded, the patient will be assigned alternative treatment at the discretion of the investigator.
Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
Requirement for prohibited concomitant therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
4-MUST
Drug128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Placebo
DrugPlacebo tablet.
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: 4-MUST, 128 mgExperimental treatment 2 interventions
Group B: 4-MUST, 256 mgExperimental treatment 2 interventions
Group C: 4-MUST, 384 mgExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Time frame
Day 29 ± 1Secondary outcomes
1
Change in the total score of gastrointestinal symptom severity according to the GSRS questionnaire on days 8, 15, 22, and 29 compared to baseline
The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.
Time frame
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 12
Response rate to therapy (proportion of patients in the group showing a reduction in pain/discomfort in the upper abdomen on the VAS by more than 30%) by day 29 compared to baseline
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Time frame
Day 29 ± 13
Response rate to therapy (proportion of patients in the group showing a reduction in pain/discomfort in the upper abdomen on the VAS by 50% or more) by day 29 compared to baseline
Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
Time frame
Day 29 ± 14
Change in manifestations of dyspeptic disorders according to the GSRS questionnaire scores on days 8, 15, 22, and 29 compared to baseline
The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.
Time frame
Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1Sponsors and contacts
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Source ClinicalTrials.gov